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Orion Pharma (Ireland) Ltd
c/o Allphar Services Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin,
Telephone: +353 1 428 7777
Fax: +353 1 428 7776
Summary of Product Characteristics last updated on medicines.ie: 30/03/2010
SPC Indivina

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 30/03/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Feb-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In section 9 (Date of First Authorisation/Renewal of the Authorisation, Date of last renewal: 10 December 2009
In setion 10 (Date of Revision of the Text) February 2010
Updated on 15/08/2006 and displayed until 30/03/2010
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   06/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

The MA number has been amended and minor typing errors have been corrected.
Updated on 15/04/2005 and displayed until 15/08/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Updated on 05/08/2004 and displayed until 15/04/2005
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Updated on 04/06/2003 and displayed until 05/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Medroxyprogesterone Acetate
  Estradiol valerate